plastic-material-food-contact

FCM and Articles Regulation, Annex I - Authorised Substances

EU. Union List of Authorised Substances: Annex I, Plastics Food Contact Regulation 10/2011/EU, as amended by Regulation 2020/1245/EU, 3 September 2020

This list contains the Union list of authorised monomers, other starting substances, macromolecules obtained from microbial fermentation, additives and polymer production aids. It is taken from Annex I of the Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food.

Last updated 20 May 2022. Database contains 1072 unique substances/entries.
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615-678-9
71878-19-8
740
81200
yes
yes
3 mg/kg
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618-352-4
9003-07-0
550
81060
yes
no
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232-417-0
8017-16-1
534
80720
yes
no
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-
-
534
80720
yes
no
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-
-
79
80640
yes
no
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-
1010121-89-7
804
80510
yes
no
Only to be used as polymer production aid in polyethylene (PE), polypropylene (PP) and polystyrene (PS).
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-
90751-07-8
790
80480
yes
no
5 mg/kg
Average molecular weight not less than 2400 Da.
Residual content of morpholine ≤ 30 mg/kg, of N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine < 15000 mg/kg, and of 2,4-dichloro-6-morpholino-1,3,5-triazine ≤ 20 mg/kg.
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617-335-9
82451-48-7
790
80480
yes
no
5 mg/kg
Average molecular weight not less than 2400 Da.
Residual content of morpholine ≤ 30 mg/kg, of N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine < 15000 mg/kg, and of 2,4-dichloro-6-morpholino-1,3,5-triazine ≤ 20 mg/kg.
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630-556-5
124578-12-7
812
80350
yes
no
Only to be used in plastics up to 0,1 % w/w.
Prepared by the reaction of poly(12-hydroxystearic acid) with polyethyleneimine.
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500-140-7
58128-22-6
875
80345
yes
yes
5 mg/kg
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608-428-5
29894-35-7
668
80240
yes
no
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614-498-8
68441-17-8
811
80077
yes
no
60 mg/kg
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618-339-3
9002-88-4
549
80000
yes
no
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-
-
979
79987
yes
no
Only to be used in polyethylene terephthalate (PET) at a maximum level of 5 % w/w.
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923-642-1
106392-12-5
551
79920
yes
no
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611-024-1
9003-11-6
551
79920
yes
no
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618-558-4
9046-01-9
578
79600
yes
no
5 mg/kg
For materials and articles intended for contact with aqueous foods only.
Polyethyleneglycol (EO ≤ 11) tridecyl ether phosphate (mono-and dialkyl ester) with a maximum 10 % content of polyethyleneglycol (EO ≤ 11) tridecylether.
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618-424-5
9005-71-4
573
79440
yes
no
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618-422-4
9005-70-3
572
79360
yes
no
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1 - 6.5 moles ethoxylated
500-020-4
9005-67-8
571
79280
yes
no
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618-421-9
9005-66-7
570
79200
yes
no
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1 - 6.5 moles ethoxylated
500-019-9
9005-65-6
569
79120
yes
no
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1 - 6.5 moles ethoxylated
500-018-3
9005-64-5
568
79040
yes
no
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618-404-6
9004-97-1
563
78320
yes
yes
42 mg/kg
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-
-
78
77897
yes
no
5 mg/kg
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-
-
77
77733
yes
no
0.05 mg/kg
Only for use in PET.
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-
-
76
77732
yes
no
0.05 mg/kg
Only for use in PET.
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-
-
799
77708
yes
no
1.8 mg/kg
In compliance with the maximum ethylene oxide content as laid down in the purity criteria for food additives in Commission Regulation (EU) No 231/2012.
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-
-
75
77702
yes
no
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1 - 6.5 moles ethoxylated
500-147-5
61788-85-0
704
77600
yes
no
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1 - 6.5 moles ethoxylated
500-151-7
61791-12-6
708
77520
yes
no
42 mg/kg
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-
-
74
77440
yes
yes
42 mg/kg
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680-598-3
70142-34-6
737
77370
yes
no
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-
-
73
76866
yes
yes
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-
-
73
76866
yes
yes
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608-670-1
31831-53-5
672
76845
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 0,5 % (w/w).
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608-670-1
31831-53-5
672
76845
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 0,5 % (w/w).
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-
-
72
76815
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 5 % (w/w).
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843-673-3
73018-26-5
797
76807
yes
yes
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843-673-3
73018-26-5
797
76807
yes
yes
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-
-
71
76730
yes
no
6 mg/kg
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-
661476-41-1
782
76725
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 1 % (w/w).
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-
167883-16-1
776
76723
yes
no
The fraction with molecular weight below 1000 Da shall not exceed 1,5 % (w/w).
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613-156-5
63148-62-9
575
76721
yes
no
Viscosity at 25 °C not less than 100 cSt (100 × 10-6 m2/s).
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-
-
70
76463
yes
no
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-
-
820
76420
yes
no
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-
-
729
75105
yes
no
Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC;(c)technical support agent in concentrations up to 0,1 % in the final product.
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-
-
729
75105
yes
no
Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC;(c)technical support agent in concentrations up to 0,1 % in the final product.
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247-977-1
26761-40-0
729
75105
yes
no
Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC;(c)technical support agent in concentrations up to 0,1 % in the final product.
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247-977-1
26761-40-0
729
75105
yes
no
Only to be used as: (a)plasticiser in repeated use materials and articles;(b)plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC;(c)technical support agent in concentrations up to 0,1 % in the final product.
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